Regeneration of articular cartilage in grade II, III and IV gonarthrosis by articular infiltration of MSV*

ClinicalTrials.gov Identifier: NCT01183728
Nº EudraCT: 2009-017405-11

Objectives

Clinical trial to evaluate the efficacy and safety of treatment with autologous expanded bone marrow mesenchymal stem cells for gonarthrosis, as well as its capacity for cartilage regeneration.

Methodology

Phase I-II, open label, prospective and unicentric clinical trial. 12 patients were included, both men and women aged 49 years old on average, with gonarthrosis grade II, III and IV of Kellgren and Lawrence. 8 out of 12 patients had a surgical history of meniscus and/or ligaments.

A single injection of autologous expanded bone marrow mesenchymal stem cells in knee joint was performed, and changes were evaluated at 6, 12 and 24 months.

Safety was determined by the absence of toxic and/or adverse effects (severe adverse effects [AE]).

Efficacy was evaluated with clinical improvement criteria and imaging characteristics (MRI T2 Mapping Cartigram®) denoting cartilage regeneration.

Results

Safety
There have been no significant adverse effects related to cell treatment.

Efficacy
The efficacy of the analgesic effect was close to 70% and the onset of action was quick (85% of patients with improvement at 3 months). In turn, the degree of disability and the quality of life of patients also improved significantly.
Magnetic Resonance Imaging (MRI) detected significant improvements in articular cartilage regeneration in 11 out of 12 patients.

Conclusions

Intra-articular percutaneous infusion of expanded mesenchymal stem cells for knee osteoarthritis significantly reduces pain and disability, showing a tendency to articular cartilage regeneration that is maintained after 24 months of follow-up. In turn, it has a good safety profile.

Publications

Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013;95(12):1535-1541.

Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014;97(11):e66-68.

Soler R, Munar A, Soler F, et al. Treatment of Knee Osteoarthritis with Autologous Expanded Bone Marrow Mesenchymal Stem Cells: 50 Cases Clinical and MRI Results at One Year Follow-Up. J Stem Cell Res Ther. 2015;5(6).


STUDY DESCRIPTION

Unicentric study
Development phase: I-II
Status: completed
PEI: 10-134
Nº EudraCT: 2009-017405-11
Code: MSV-ARTRO-2009-01
ClinicalTrials.gov: NCT01183728
Sponsor: Teknon Foundation – ITRT
CEIC: Centro Médico Teknon
Control: Spanish Medicine Agency (AEMPS)
CRO: ADKNOMA
Investigators: L Orozco, R Soler Rich, F Soler, A Sánchez, A Munar, J García Sancho, M Alberca, M Huguet, J Sentís
Scientific collaboration: JC Vilanova, S Trattnig, X Peirau
Participating entities: Centro Médico Teknon, CETIR Clínica del Pilar, Teknon Foundation, IBGM (Valladolid University and CSIC).
Funding: Aid to Independent Investigation 2011, Teknon Foundation.

*MSV: Autologous bone marrow stem cells expanded ex vivo with a GMP procedure developed by Instituto de Biología Genética Molecular (IBGM) – Valladolid.